MedTrace Logo

Study to Evaluate Safety and Efficacy of Rifamycin SV Multi-Matrix System (MMX) for the Treatment of Traveler's Diarrhea (TD)

NCT01142089 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2018-06-08

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to determine whether Rifamycin SV MMX is a safe and effective treatment for Traveler's Diarrhea.

Conditions

  • Traveler's Diarrhea

Interventions

DRUG

Placebo

Placebo (two matching tablets) orally twice daily for 3 days (72 hours).

DRUG

Rifamycin SV MMX

Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours).

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    collaborator INDUSTRY

  • Cosmo Technologies Ltd

    lead INDUSTRY

Principal Investigators

  • Herbert DuPont, MD · Bausch Health Americas, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-27
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • Guatemala
  • Mexico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01142089 on ClinicalTrials.gov